Recombinant Hepatitis B Vaccine

AIM Honesty is a hepatitis B vaccine manufacturer from China. Our Recombinant Hepatitis B Vaccine comes in 0.5ml vials (or syringes), with each dose containing 10μg or 20μg of HBsAg.  It is administered via intramuscular injection to stimulate the body's immune response against the hepatitis B virus.

How Did Recombinant Hepatitis B Vaccines Develop to Their Current State?

As a landmark achievement in the fields of biotechnology and vaccinology, the early foundations of recombinant hepatitis B vaccines can be traced back to 1965, when Baruch Blumberg discovered the "Australia antigen," later identified as hepatitis B surface antigen (HBsAg).

In 1970, 42-nanometer HBV virus particles (Dane particles) and a large number of 22-nanometer HBsAg subviral spheres were observed. These collectively laid the foundation for vaccine development.

In 1981, the first-generation plasma-derived vaccine was approved. HBsAg particles were purified and inactivated from the plasma of asymptomatic carriers and used to produce the "Heptavax" vaccine.

However, at this time, safety concerns regarding potential blood-borne pathogens and limited plasma supply necessitated the continued search for new methods.

Around the same time, between 1979 and 1986, breakthroughs in recombinant DNA technology occurred.  First, William Rutter, Pablo Valenzuela, and their colleagues cloned the HBV S gene and expressed HBsAg in E. coli, demonstrating that recombinant antigens could be produced.  Later, the same research group transferred the S gene into Saccharomyces cerevisiae (baker's yeast), and found that the HBsAg secreted by the yeast spontaneously assembled into 22-nanometer immunogenic particles, identical to those found in human serum.

In 1986, Merck's yeast-derived "Recombivax HB" became the first recombinant hepatitis B vaccine approved by the US FDA, ushering in an era of producing subunit vaccines without the need for human blood.

By the early 1990s, yeast-based recombinant vaccines had largely replaced plasma-derived vaccines globally. Subsequent improvements have continued to this day, leading to the development of further innovative formulations with more effective and enhanced protective effects.

Global Replacement and Subsequent Developments

1990s: Development of third-generation vaccines containing pre-S1/pre-S2 antigens (expressed in mammalian cells) to improve immunogenicity in non-responders. From the 2000s to the present: Further innovations include adjuvant formulations (e.g., AS04, CpG-1018) and trivalent vaccines (S + pre-S1 + pre-S2), which enhance and accelerate seroprotection, especially in the elderly.

Recombinant hepatitis B vaccines have evolved from the groundbreaking recombinant DNA product in 1986 into a continuously improving platform, laying the foundation for global hepatitis B elimination strategies.

Precautions for Vaccination

Common Adverse Reactions:

After receiving the Recombinant Hepatitis B Vaccine, pain and tenderness may occur at the injection site within 24 hours. In most cases, these symptoms disappear spontaneously within 2-3 days.

Occasional Adverse Reactions:

(1) Transient fever may occur within 72 hours after vaccination, generally lasting 1-2 days and resolving spontaneously.

(2) Mild to moderate redness, swelling, and pain may occur at the injection site. These generally last 1-2 days and resolve spontaneously without treatment.

Rare Adverse Reactions:

(1) Induration may occur at the injection site, generally resolving spontaneously within 1-2 months.

(2) Local aseptic suppuration: The pus is usually repeatedly aspirated with a syringe. In severe cases (ulcer formation), debridement to remove necrotic tissue is required. The course of the disease is longer, but it can eventually be absorbed and healed.

(3) Allergic reactions: Allergic rash, Arthus reaction. The Arthus reaction generally occurs about 10 days after vaccination, with prolonged local redness and swelling. Systemic and local treatment with corticosteroids may be used.

(4) Anaphylactic shock: This generally occurs within 1 hour after vaccination.  Epinephrine and other medications should be administered promptly for emergency treatment.

Product Specification

Compared to other technical routes, RECVAX® were produced with a more rigorous pharmacopeia standard, which improve the quality and safety of the product.

Why Choose Our Product?

RECVAX® patented adjuvant technology utilizes in-situ adsorption technology, allowing for sustained antigen release after administration, enhancing the immune response and improving immunogenicity. We are highly experienced,

with our product having been on the market for over 20 years and widely used in China.  A study led by Academician Li Lanjuan evaluated its effectiveness, showing that after a booster immunization with 10 μg of RECVAX® (Hansenula polymorpha) vaccine using a 0-1-6 month schedule, the HBs antibody seropositivity rate reached 83.4% at 1, 5, and 8 years post-booster. This was the best booster immunization effect among the four different vaccines tested.

Production Details

Professional and modern production workshops are the cornerstone of high-quality products!